Intervention type

Phase

Drug names

Primary outcome measures

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/10/2003

Overall trial end date

01/10/2004

Reason abandoned

Eligibility

Participant inclusion criteria

1. Histologically confirmed Hodgkin's disease2. Stages IA, IB, and IIA with one or more of the following risk factors: 2.1. Massive mediastinal involvement (tumour one third or more of the maximum intrathoracic diameter) 2.2. Extranodal involvement 2.3. High erythrocyte sedimentation rate (ESR) (more than or equal to 50 mm; more than or equal to 30 mm in patients with B symptoms)2.4. Three or more involved lymph node areas; stage IIB and high ESR (more than or equal to 30 mm) and/or three or more involved lymph node areas3. No prior therapy for Hodgkin's disease4. Age: 18 to 60 years5. No major organ dysfunction6. Life expectancy more than three months7. Written informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Not provided at time of registration

Participant exclusion criteria

1. Incomplete staging2. Major organ dysfunction (Chronic Obstructive Pulmonary Disease [COPD] with respiratory insufficiency, symptomatic Coronary Heart Disease [CHD], cardiomyopathy or heart failure [ejection fraction less than 50%], severe hypertension, non-treatable infections, white blood count less than 3000/mm^3 or platelets less than 100,000/mm^3, creatinine clearance less than 60 ml/min, bilirubin more than 2 mg/dl, Glutamic-Oxaloacetic Transaminase [GOT]/ASpartate aminoTransferase [AST] more than 100 U/l, Glutamic-Pyruvic Transaminase [GPT]/ALanine aminoTransferase [ALT] more than 100 U/l, Human Immunodeficieny Virus [HIV]-infection)3. Composite lymphoma4. Prior chemotherapy or radiotherapy5. Any history of another malignancy in the last five years (except for cervical carcinoma in situ and fully resected melanoma TNMpT1)6. Pregnant or lacating women7. World Health Organisation (WHO) performance status more than two8. Long term use of corticosteroids (e.g. for arthritis) or antineoplastic substances (e.g. methotrexate)9. Expected non compliance10. Current therapy for epilepsy11. Intolerabilities against study drugs12. Inability to give truly informed consent